Clin2
NCT06167213Possibly a fitNot yet recruiting

New heart valve for failing mitral valve

Mitral RegurgitationMitral Valve DiseaseMitral Stenosis

Part of Heart & circulation clinical trials.

This trial tests a new, less invasive heart valve (called SAPIEN X4) placed through a vein in your leg to replace a failing mitral valve that was previously repaired or replaced. It is for people who are at high risk for open-heart surgery and have a leaky or narrowed mitral valve.

Summary written for real people, not researchers, by Clin2.

Phase
N/A
Enrollment
125 people
Ages
Any age
Study type
Interventional

Who can take part

  • You have a mitral valve (the valve between the heart's left chambers) that is failing—either a previously replaced valve or your own valve with a ring from past surgery—and it is now narrowed or leaking at least moderately.
  • Your heart care team has determined you are at high risk for open-heart surgery.
  • You are experiencing symptoms like shortness of breath or fatigue with everyday activities (NYHA class II or more).
  • You are able to have the valve replacement done through a vein in your leg (femoral access).
  • You do not have other serious heart valve problems, severe right heart weakness, or a recent heart attack or stroke.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

Similar studies

Other trials that look related to this one.

NCT04153292Recruiting
Testing a valve procedure for severe mitral regurgitation

This trial studies a minimally invasive mitral valve repair/replacement approach for people with severe mitral regurgitation (leaky mitral valve) who are not good candidates for standard surgery or catheter options. It may help improve symptoms by treating the leaky valve when other treatments aren’t suitable.

Huntsville, Alabama
NCT06552689Recruiting
Testing Sutra Hemi-valve for leaky mitral valve

This trial tests a new, less invasive heart valve (Sutra Hemi-valve) for people with a leaky mitral valve who cannot have standard surgery. The valve is delivered through a vein in your leg, so you avoid open-heart surgery.

Hamilton
NCT05496998Recruiting
Heart valve replacement using a catheter for leaking mitral valve

This trial studies a catheter-based procedure to replace the mitral valve in people with severe (or specific moderate) mitral valve leakage that causes symptoms. It may help by reducing leaking and related symptoms when standard surgery or less invasive fixes aren’t suitable for you.

Aarhus
NCT03958773Enrolling by invitation
Transcatheter treatment for severe leaking mitral valve

This study tests a new catheter-based system to treat severe mitral valve leaking when open-heart surgery is considered high risk. It may help improve blood flow and symptoms by repairing the valve without open surgery, using ultrasound guidance and follow-up visits to track safety and results.

Kaunas
NCT05172973Recruiting
New valve procedure for failing aortic bioprosthetic valves

This trial studies whether a new transcatheter aortic valve (SAPIEN X4) is safe and works well in people whose previously implanted aortic valve is now failing. It may help reduce valve symptoms in higher-surgery-risk patients who are not good candidates for open-heart valve replacement.

Newport Beach, California
NCT05172960Recruiting
Study of a new heart valve for severe aortic stenosis

This trial tests a new version of a heart valve (SAPIEN X4) placed without open-heart surgery. It's for people with severe aortic stenosis who have symptoms like shortness of breath or chest pain.

La Jolla, California

Hear when a new Mitral Regurgitation trial opens

We’ll email you when one opens — at most once a week, no account needed, unsubscribe anytime.